- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …mid-term, long-term). These will include but not limited to Group Heads in Clinical Development , Asset & Portfolio Management, Global Clinical Operations, ... and aligned guidance to asset teams to enable seamless tumor-specific clinical development and strategy. Responsibilities - Accountable for developing… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and immune disorders. Summary Oversees early -stage trials, such as global clinical development program for multiple product candidates with one or more ... indications; Interacts with our Discovery and Research programs for development of early clinical studies. Provides senior level clinical representation… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …with facilities in Lexington, MA and Plainsboro, NJ. We support programs from early research through late-stage clinical development . We are building ... will work closely with cross-functional project teams, including Clinical Development , Clinical Operations, Biometrics,... development and regulatory requirements of a clinical program. The Director will provide high… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …with facilities in Lexington, MA and Plainsboro, NJ. We support programs from early research through late-stage clinical development . We are building ... part in the unique opportunity to bring highly innovative pharmaceutical products through clinical development to market. The candidate is a team player, detail… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …team (data management, clinical operation and other functions) to implement clinical development plan: study ideation, protocol development , review case ... Science function. This position may be at the executive director level or senior director level, depending...Clinical Science staff in the creation of the development strategy ensuring the highest scientific/medical standards in accordance… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …well as with early -stage compounds required- Excellent understanding of the clinical development and life cycle of oncology medicines required- Strong ... functions including but not limited to Commercial, Marketing, Medical, & Clinical Development ,ResponsibilitiesGlobal Market Access Strategy- Lead the … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …of contact for interactions with regulatory-agency clinical reviewing divisions on clinical matters; Represents Clinical Development in Project Teams, ... eg NCI.Scientific, Program related: Integrated Study Team (IST) representative: Creates early development plan and contributes to overall development… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …an advanced degree required.6-9 years of experience with a bachelor's degree required. Clinical development or post-marketing experience to be able to apprehend ... (SAPs) and statistical outputs (tables, figures, and listings [TFLs]), and other clinical study documentsAuthors or oversees the development of safety sections… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …veterans and people with disabilities. Summary The Associate Director , Clinical Data Standards, is responsible for the development , maintenance, and ... pipeline.Proactively identify Data Standards gaps and resolve issues related to clinical data standards development throughout the trial lifecycle.Standardize… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …outcomes (PROs), ensuring the payer perspective is incorporated in the assigned clinical development programs and the evidence needed to support optimal ... alignment with key global and regional functions. The Global Director of HEOR & RWE Oncology will lead the...with HEOR sections in target product profiles (TPPs), product development plans, clinical development plans,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Leads and Biomarker Leads globally in the evaluation and development of clinical biomarker assays and vendor selection for early and late-stage Daiichi ... progress and risks toward the timely testing of biomarkers in clinical development programs. The individual will be directly involved in collaborating globally… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …therapeutic compounds. This includes working with scientists in Research, Translational Science, Clinical Development , in addition to colleagues in QCP. QSP ... aid in target prioritization, therapeutic modality selection, biomarker characterization and early clinical trial designInteract with, and possibly lead,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …of companion diagnostics (CDx) in support of projects within Daiichi Sankyo's Early and Late-Stage Development Portfolio. The individual will play a ... CDx portfolio leader, covering all areas from CDx assay development through CDx approval and launch. May act as...launch. May act as CDx representative to GPT for early -stage programs.Contributes to CDx Partner evaluation and selection activities… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …expert knowledge on safety biomarkers that might be used in preclinical and clinical development by closely collaborating w Research and Precision Medicine. ... and Pharmacovigilance (CSPV) must be embedded in R&D as early as possible. This led us to create the...candidates by the start of the FIH trial (DP1).- Clinical Development and Post Marketing: Consult with… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …responsible for the regulatory CMC (Chemistry, Manufacturing and Controls) activities from early development to post-approval phase for biological, Cell and Gene ... teams along with other functional teams leading to sound scientific development programs and successful registration for new compounds. Performs collaborative… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …implementation of companion diagnostics (CDx) in support of projects within Daiichi Sankyo's Early and Late Stage Development Portfolio. The individual will play ... Program Teams (GPT) for the therapeutic, covering all areas from CDx assay development through CDx approval and launch- Leads CDx Partner evaluation and selection,… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …with facilities in Lexington, MA and Plainsboro, NJ. We support programs from early research through late-stage clinical development . We are building ... will report to Senior Global Safety Lead/ Director /Senior Director - Safety Surveillance, US East Coast Development...decisions (phase I trials) Provide safety input to Product Development Plan (PDP), Trial Outline, Protocol, Clinical … more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …with facilities in Lexington, MA and Plainsboro, NJ. We support programs from early research through late-stage clinical development . We are building ... manage preparation of the written deliverables that support the clinical development and regulatory requirements of a...program. Relationships The Senior Medical Writer reports to a Director of Medical Writing. The Senior Medical Writer is… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- ** Director , Biostatistics Early Clinical Development Gene Therapy** The Director of Biostatistics provides leadership and guidance as the statistical ... with Strategic Project Teams on clinical and regulatory strategies for clinical development , and to represent statistical issues in regulatory agency… more
- Bristol Myers Squibb (Princeton, NJ)
- …trials and lead the clinical development team. Experience in early clinical development of neurodegenerative and/or neuropsychiatric indications is a ... careers.bms.com/working-with-us . The Director will be the clinical lead to progress early clinical...and/or neuropsychiatry is a plus. **Functional Area Description** The Early Clinical Development function is… more
